Pharmaceutical Dissolution Testing, Bioavailability, and Bioequivalence

Science, Applications, and Beyond

Umesh V. Banakar

• Verlag: Wiley
• Jahr: 2021
• ISBN:
  9781119634638
• Auflage: 1
• Thema: Medicine
• Thema: Pharmacology

Explore the cutting-edge of dissolution testing in an authoritative, one-stop resource

In Pharmaceutical Dissolution Testing, Bioavailability, and Bioequivalence: Science, Applications, and Beyond, distinguished pharmaceutical advisor and consultant Dr. Umesh Banakar delivers a comprehensive and up-to-date reference covering the established and emerging roles of dissolution testing in pharmaceutical drug development.

After discussing the fundamentals of the subject, the included resources go on to explore common testing practices and methods, along with their associated challenges and issues, in the drug development life cycle.

Over 19 chapters and 1100 references allow practicing scientists to fully understand the role of dissolution, apart from mere quality control. Readers will discover a wide range of topics, including automation, generic and biosimilar drug development, patents, and clinical safety.

This volume offers a one-stop resource for information otherwise scattered amongst several different regulatory regimes. It also includes:

• A thorough introduction to the fundamentals and essential applications of pharmaceutical dissolution testing
• Comprehensive explorations of the foundations and drug development applications of bioavailability and bioequivalence
• Practical discussions about solubility, dissolution, permeability, and classification systems in drug development
• In-depth examinations of the mechanics of dissolution, including mathematical models and simulations
• An elaborate assessment of biophysiologically relevant dissolution testing and IVIVCs, and their unique applications
• A complete understanding of the methods, requirements, and global regulatory expectations pertaining to dissolution testing of generic drug products

Ideal for drug product development and formulation scientists, quality control and assurance professionals, and regulators, Pharmaceutical Dissolution Testing, Bioavailability, and Bioequivalence is also the perfect resource for intellectual property assessors.

Inhaltsverzeichnis

• Cover
• Table of Contents
• Title Page
• Copyright
• Dedication
• Foreword
• Foreword
• Preface
• Acknowledgments
• 1 Pharmaceutical Dissolution Testing: Fundamentals and Essential Applications (An Overview)
• 2 Bioavailability (BA) and Bioequivalence (BE): Fundamentals and Applications in Drug Product Development
• 3 Solubility, Dissolution, Permeability, and Classification Systems
• 4 Understanding the Mechanics of Dissolution: Mathematical Models and Simulations
• 5 Dissolution Testing Methods: Necessity Is the Mother of Invention!
• 6 Essentials of Dissolution Testing of Pharmaceutical Systems
• 7 Dissolution/Release Test Data (Profile): Requirements, Analyses, and Regulatory Expectations
• 8 Automation in Dissolution Testing: Recent Advances and Continuing Challenges!
• 9 In vitro–In vivo Correlations (IVIVCs): What Makes Them Challenging!
• 10 Biorelevant Dissolution/Release Test Method Development for Pharmaceutical Dosage Forms
• 11 Bioavailability Prediction Software: Hype or Reality!
• 12 Challenges and Unique Applications of IVIVC in Drug Development
• 13 Dissolution Testing in Generic Drug Development: Methods, Requirements, and Regulatory Expectations/Requirements
• 14 Successful Bioequivalence Investigations: Current Challenges and Possible Solutions!
• 15 Beyond Guidance(s): Convincing Regulatory Authorities Through Creative Dissolution Data Interpretation
• 16 Biosimilars: The Emerging Frontier for Generics – Role of Dissolution Testing!
• 17 Patentability of Drug Product Based on Dissolution Data: Intellectual Property Considerations!
• 18 Setting Up Clinical Therapeutics Safety‐Based QC Specifications for Dissolution Testing of a Finished Product
• 19 Unlocking the Mystery(ies) While Predicting Bioavailability from Dissolution
• Index
• End User License Agreement